NCT01391286

Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced Eyelash Hypotrichosis

Completed Phase 3 Results posted Last updated 8 July 2019

What this trial tests

Phase 3 trial testing bimatoprost solution 0.03% in Eyelash Hypotrichosis in 36 participants. Completed in 25 May 2012.

Timeline

1 July 2011

Primary endpoint
25 May 2012

25 May 2012

Quick facts

Lead sponsor	Allergan
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	36
Start date	1 July 2011
Primary completion	25 May 2012
Estimated completion	25 May 2012
Sites	1 location across Japan

Drugs / interventions tested

• bimatoprost solution 0.03%
• bimatoprost vehicle solution

Conditions studied

• Eyelash Hypotrichosis — all drugs for Eyelash Hypotrichosis →

Sponsor

Allergan — full company profile →

Who can join

20 and older, any sex, with Eyelash Hypotrichosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA) Primary · Baseline, Month 4

The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.

Group	Value	95% CI
Bimatoprost Solution 0.03%	88.9
Bimatoprost Vehicle Solution	27.8

Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA) Secondary · Baseline, Month 4

Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).

Baseline

Group	Value	95% CI
Bimatoprost Solution 0.03%	5.70	2.5 – 7.3
Bimatoprost Vehicle Solution	5.00	1.4 – 7.2

Change from Baseline at Month 4

Group	Value	95% CI
Bimatoprost Solution 0.03%	2.70	0.6 – 6.3
Bimatoprost Vehicle Solution	0.6	-0.6 – 3.3

Change From Baseline in Eyelash Thickness as Measured by DIA Secondary · Baseline, Month 4

Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm\^2). A positive change from Baseline indicated fuller eyelashes (improvement).

Baseline

Group	Value	95% CI
Bimatoprost Solution 0.03%	0.60	0.1 – 1.5
Bimatoprost Vehicle Solution	0.45	0.1 – 1.1

Change from Baseline at Month 4

Group	Value	95% CI
Bimatoprost Solution 0.03%	0.80	0.1 – 2.0
Bimatoprost Vehicle Solution	0.25	-0.2 – 0.9

Change From Baseline in Eyelash Darkness as Measured by DIA Secondary · Baseline, Month 4

Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).

Baseline

Group	Value	95% CI
Bimatoprost Solution 0.03%	140.15	98.7 – 173.7
Bimatoprost Vehicle Solution	144.98	123.8 – 181.4

Change from Baseline at Month 4

Group	Value	95% CI
Bimatoprost Solution 0.03%	-19.40	-53.4 – 3.0
Bimatoprost Vehicle Solution	-10.03	-23.5 – 33.6

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Bimatoprost Solution 0.03%

Serious: 0/18 (0%)

Deaths: —

Bimatoprost Vehicle Solution

Serious: 2/18 (11%)

Deaths: —

Serious adverse events (2 terms)

Reaction	System	Bimatoprost Solution 0.03%	Bimatoprost Vehicle Solution
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Cellulitis	Infections and infestations	—	—

Other adverse events (49 terms — click to expand)

Reaction	System	Bimatoprost Solution 0.03%	Bimatoprost Vehicle Solution
Nasopharyngitis	Infections and infestations	—	—
Radiation skin injury	Injury, poisoning and procedural complications	—	—
Insomnia	Psychiatric disorders	—	—
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	—	—
Hypothyroidism	Endocrine disorders	—	—
Eye pruritus	Eye disorders	—	—
Erythema of eyelid	Eye disorders	—	—
Blepharitis	Eye disorders	—	—
Cataract	Eye disorders	—	—
Dry eye	Eye disorders	—	—
Retinal haemorrhage	Eye disorders	—	—
Colitis ischaemic	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Periodontitis	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Oedema peripheral	General disorders	—	—
Pyrexia	General disorders	—	—
Sensation of pressure	General disorders	—	—
Acute sinusitis	Infections and infestations	—	—
Fungal infection	Infections and infestations	—	—
Pharyngitis	Infections and infestations	—	—
Cellulitis	Infections and infestations	—	—
Herpes zoster	Infections and infestations	—	—
Paronychia	Infections and infestations	—	—
Arthropod bite	Injury, poisoning and procedural complications	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Joint swelling	Musculoskeletal and connective tissue disorders	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	—	—
Trigger finger	Musculoskeletal and connective tissue disorders	—	—
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Hypoaesthesia	Nervous system disorders	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—
Dizziness	Nervous system disorders	—	—
Affective disorder	Psychiatric disorders	—	—
Pruritus genital	Reproductive system and breast disorders	—	—

Most-reported serious reactions: Thyroid cancer, Cellulitis.

Data from ClinicalTrials.gov NCT01391286 adverse events section.

Sponsor's own description

This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy treatment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Bimatoprost 0.03% for the Treatment of Eyelash Hypotrichosis: A Pooled Safety Analysis of Six Randomized, Double-masked Clinical Trials.
   Wirta D, Pariser DM, Yoelin SG, Arase S, et al · · 2015 · cited 3× · PMID 26203317